Ibandronic acid 150mg tablets

Šalis: Didžioji Britanija

kalba: anglų

Šaltinis: MHRA (Medicines & Healthcare Products Regulatory Agency)

Veiklioji medžiaga:

Ibandronic sodium monohydrate

Prieinama:

Zentiva

ATC kodas:

M05BA06

INN (Tarptautinis Pavadinimas):

Ibandronic sodium monohydrate

Dozė:

150mg

Vaisto forma:

Tablet

Vartojimo būdas:

Oral

Klasė:

No Controlled Drug Status

Recepto tipas:

Valid as a prescribable product

Produkto santrauka:

BNF: 06060200; GTIN: 5000283656074 5000283656067

Pakuotės lapelis

WHAT IS IN THIS LEAFLET:
1. What ibandronic acid is and what it is used for
2.
What you need to know before you take ibandronic acid
3. How to take ibandronic acid
4. Possible side effects
5. How to store ibandronic acid
6. Contents of the pack and other information 1. WHAT IBANDRONIC ACID IS AND WHAT IT IS USED FOR
The name of your medicine is Ibandronic acid 150mg
film-coated Tablets (referred to as ibandronic acid
throughout this leaflet).
Ibandronic acid belongs to a group of medicines called
BISPHOSPHONATES. It contains the active substance
ibandronic acid.
Ibandronic acid may reverse bone loss by stopping more
loss of bone and increasing bone mass in most women
who take it, even though they won’t be able to see or
feel a difference. Ibandronic acid may help lower the
chances of breaking bones (fractures). This reduction in
fractures was shown for the spine but not for the hip.
IBANDRONIC ACID IS PRESCRIBED TO YOU TO TREAT
POSTMENOPAUSAL OSTEOPOROSIS BECAUSE YOU HAVE AN
INCREASED RISK OF FRACTURES. Osteoporosis is a thinning
and weakening of the bones, which is common in
women after the menopause. At the menopause, a
woman’s ovaries stop producing the female hormone,
oestrogen, which helps to keep her skeleton healthy.
The earlier a woman reaches the menopause, the
greater her risk of fractures in osteoporosis. Other things
that can increase the risk of fractures include:
-
not enough calcium and vitamin D in the diet.
-
smoking, or drinking too much alcohol.
-
not enough walking or other weight-bearing exercise.
-
a family history of osteoporosis.
A HEALTHY LIFESTYLE will also help you to get the most
benefit from your treatment. This includes
-
eating a balanced diet rich in calcium and vitamin D
-
walking or any other weight-bearing exercise
-
not smoking; and not drinking too much alcohol. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE
IBANDRONIC ACID
DO NOT TAKE IBANDRONIC ACID
•
If you are allergic to ibandronic acid, or any of the
other ingredients of this medicine listed in section 6.
•
If you have

Prekės savybės

OBJECT 1
IBANDRONIC ACID 150MG FILM-COATED TABLETS
Summary of Product Characteristics Updated 08-Nov-2017 | Zentiva
1. Name of the medicinal product
Ibandronic acid 150 mg film-coated tablets
2. Qualitative and quantitative composition
Each film-coated tablet contains 150 mg ibandronic acid (as ibandronic
sodium monohydrate).
Excipients with known effect: each tablet contains 271 mg lactose.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated tablet.
White, oblong biconvex film coated tablets.
4. Clinical particulars
4.1 Therapeutic indications
Treatment of osteoporosis in postmenopausal women at increased risk of
fracture (see section 5.1).
A reduction in the risk of vertebral fractures has been demonstrated,
efficacy on femoral neck fractures
has not been established.
4.2 Posology and method of administration
Posology:
The recommended dose is one 150 mg film-coated tablet once a month.
The tablet should preferably be
taken on the same date each month.
Ibandronic acid should be taken after an overnight fast (at least 6
hours) and 1 hour before the first food
or drink (other than water) of the day (see section 4.5) or any other
oral medicinal products or
supplementation (including calcium).
In case a dose is missed, patients should be instructed to take one
ibandronic acid 150 mg tablet the
morning after the tablet is remembered, unless the time to the next
scheduled dose is within 7 days.
Patients should then return to taking their dose once a month on their
originally scheduled date.
If the next scheduled dose is within 7 days, patients should wait
until their next dose and then continue
taking one tablet once a month as originally scheduled.
Patients should not take two tablets within the same week.
Patients should receive supplemental calcium and/or vitamin D if
dietary intake is inadequate (see
sections 4.4 and 4.5).
The optimal duration of bisphosphonate treatment for osteoporosis has
not been established. The need for
continued treatment should be re-evaluated periodically